Kidney transplantation MedDRA version: 14.1 Level: PT Classification code 10062016 Term: Immunosuppression System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Nulojix R
Product Name: Nulojix R
Product Code: 013116-D922
Pharmaceutical Form: Concentrate and diluent for solution for infusion
Trade Name: Cyclosporine
Product Name: Cyclosporine
Phar
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients scheduled to receive a single-organ renal transplant, 18 to 65 years old at the day of inclusion. 2. Transplant from a living or deceased donor aged under 65 years. 3. Patients must have IgG-detectable positive Epstein-Barr virus serostatus. 4. Patient must have signed the written informed consent. 5. Patients must have a current or historic panel reactive antibody =30% (according to Lymphocytotoxicity-Test. The antibody screening is back followed until patients` acceptance as KTRs on the waiting list). 6. Kidney donors must have a serum creatinine = 1.5 mg/dl or 130 µmol/l. 7. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant must have a negative pregnancy test using serum performed immediately before tx. 8. Female patients must meet at least one of the following criteria: • For female patients = 50 years of age at the day of inclusion: Menopause since at least 1 year. • For female patients 40 mIU/mL. • 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy. • Correct use of an effective method of birth control (locally acting hormonal contraceptives as vaginal products, skin patches, implanted or injectable products, mechanical products such as intrauterine devices or barrier methods as diaphragm, condoms, spermicides) during the study and until a minimum of 8 weeks after the last administration of investigational medicinal product. Oral hormonal contraceptives are not acceptable. • General sexual abstinence during the study and until a minimum of 8 weeks after the last administration of investigational medicinal product. • Having only female sexual partners. • Relationships with only sterile male partners 9. Procreative male subjects should be advised to avoid unprotected sex throughout the study and until sperm produced during the period of drug exposure has been cleared (10 weeks). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. History of lymphoproliferative disease. 2. Patients with a proven or suspected history for tuberculosis who have not been previously treated for latent infections. 3. Patients with other transplanted organs (heart, liver, pancreas) or with a history of bone marrow transplantation. 4. Patients with previous renal graft. 5. Patients with a malignant disease. 6. Patients with an infectious hepatitis B or C or a positive HIV status. 7. Patients unable to give their written consent (e. g. stroke patients or those with severe dementia or mental disability). 8. Pregnant or lactating females. 9. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the study begin. 10. Patients that are in a physical state that, in the opinion of the investigator, might interfere with the objectives of the study or pose additional risk to the patients due to participation in the study (e. g. patients with an elevated risk for bleeding* after kidney biopsy, patients with an immunological disease predisposing for rejection); *Hypocoagulability: thrombocytes < 100.000 /µl, Quick test < 70 % or INR < 2.0. 11. Patients with a severe cachexia (BMI < 16). 12. Patients with a history of allergy or drug reaction against the investigational medicinal products. 13. Patients receiving an ABO-incompatible kidney donation from a living donor. 14. Patients being pre-sensitized for donor specific antibodies before kidney transplantation using special lymphocyte depleting immunosuppressive protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore a number of biomarkers from plasma, serum and renal tissue to describe the impact of different strategies for immunosuppression (Belatacept, Cyclosporine) on the immune-system that may explain differences in long-term outcome.;Secondary Objective: The main secondary objective is to evaluate the diagnostic accuracy of various biomarkers (FACs panel, chemokines and cytokines) regarding the relevancy of an acute rejection episode with lower tendency to relapse and without relevant deterioration of renal function in the follow up and having regard to the randomly assigned immunosuppression. Renal function of the graft was favorable by a delta eGFR of 10 ml/min after 36 months even in a trial with marginal kidney donations as compared to renal transplant recipients under Cyclosporine (Benefit extended trial). Using markers of kidney toxicity in plasma, renal tissue and urine, we will describe whether this effect was due to a lower kidney toxicity of the drug as compared to Cyclosporine. ;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactInvestigator
Dept. Of Nephrology and Hypertensiology
Outcome results
None listed